NCT04583254 Hypofractionated External-beam RadiOtherapy for Intact Cervical Cancer (HEROICC-Trial): A Feasibility Study
| NCT ID | NCT04583254 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's |
| Condition | Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2021-02-04 |
| Primary Completion | 2023-12-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 48 participants in total. It began in 2021-02-04 with a primary completion date of 2023-12-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
External radiation given in 25 fractions or so together with weekly chemotherapy and followed by 3 or 4 fractions of brachytherapy is the standard of care for patients with locally advanced cervical cancer. This study investigates the role of shortened external radiotherapy regimen (hypofractionated radiotherapy) by randomizing patients to this experimental regimen versus the standard of care.The purpose of this study is to access the feasibility of patient accrual to this trial in the Canadian setting and to provide an initial evaluation of cancer response and treatment tolerability.
Eligibility Criteria
Inclusion Criteria: * Age 18 years or older * International Federation of Gynecology and Obstetrics (FIGO) IA or IB1 cervical cancers if not surgical candidates, but amenable to definitive chemoradiotherapy as proposed in this trial. * FIGO Stage IB2, IB3, IIA or IIB cervical cancers * FIGO stage IIIC1 cervical cancers are candidates but must meet all the following criteria: 1. largest node is less than 3 cm 2. less than 3 pathological nodes 3. No nodes located in the common iliac chain. 4. Cervical confined or with parametrial invasion * Histologically-confirmed invasive uterine cervical carcinoma of subtypes squamous cell, adenocarcinoma or adenosquamous cell * Candidate for definitive chemoradiotherapy to be delivered with weekly cisplatin * Brachytherapy candidate Exclusion Criteria: * FIGO stage IIIA, IIIB, IIIC2, IVA or IVB * FIGO stage IIIC1 with node greater than 3 cm, common iliac node or greater than 2 pathological nodes * Previous pelvic or abdominal radiotherapy * Patients requiring paraaortic nodal irradiation * Inflammatory bowel disease * Connective tissue disorder (eg. scleroderma, systemic lupus erythematous) * Neuroendocrine, glassy cell, small cell, adenoid cystic carcinoma, adenoid basal carcinoma, clear cell, serous, endometrioid, verrucous carcinoma, melanoma, and sarcoma histologies * Patient unable to undergo MR scan * Eastern Cooperative Oncology Group (ECOG) performance status greater than 3 * Not a cisplatin candidate
Contact & Investigator
Lucas C Mendez, MD
PRINCIPAL INVESTIGATOR
London Health Sciences Centre, Lawson Health Research Institute
Frequently Asked Questions
Who can join the NCT04583254 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04583254 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04583254 currently recruiting?
Yes, NCT04583254 is actively recruiting participants. Contact the research team at Lucas.Mendez@lhsc.on.ca for enrollment information.
Where is the NCT04583254 trial being conducted?
This trial is being conducted at Kelowna, Canada, London, Canada, Toronto, Canada.
Who is sponsoring the NCT04583254 clinical trial?
NCT04583254 is sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. The principal investigator is Lucas C Mendez, MD at London Health Sciences Centre, Lawson Health Research Institute. The trial plans to enroll 48 participants.
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